Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465342
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
LUTEIN BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION AMD
Sponsor:
OFFHEALTH SpA
Organization:
OFFHEALTH SpA
Study Overview
Official Title:
PROSPECTIVE MULTICENTER OBSERVATIONAL CLINICAL INVESTIGATION OF LUTEIN USE BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION AMD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the clinical investigation is to evaluate the performance safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 AREDS classification in one or both eyes
Detailed Description:
Lutein is a dietary carotenoid which together with its isomer zeaxanthin is the main component of the macular pigment of the retina
Clinical studies have shown that prolonged oral lutein supplementation is safe and is associated with a reduction in the risk of progression from early to advanced stages of Age-Related Macular Degeneration AMD However patient compliance due to daily oral intake of lutein tablets for a prolonged period of life is still limited Additionally an obstacle to oral supplementation is the variable absorption of lutein through the digestive route
An iontophoresis method for conveying substances into the eye has been known for some time and already used in the treatment of keratoconus In this case the substance conveyed is Riboflavin
A medical device is now available with the following intended use to combat all oxidative pathologies of the retina and macula and in particular in the prevention of AMD and in the management of the patient during the evolution of the pathology
The device consists of an iontophoresis system with scleral applicator and an ophthalmic liquid lutein solution both of which have already obtained the CE mark The system therefore includes a generator called K-IONO CE in class IIa and a kit called IONTORETINA which includes a sterile 2 ml vial of lutein CE in class IIb the forward and return electrode which consists of a scleral iontophoresis applicator and an ophthalmic liquid solution of lutein The topical application of lutein has the advantage of improving the patients compliance with lutein supplementary therapy compared to oral intake of the carotenoid Furthermore in situ application would allow high therapeutic concentrations of lutein to be reached in the macular area in a very short period of time hours compared to oral intake months Publicly available clinical data on scleral iontophoresis or lutein supplementation have not demonstrated any safety-related adverse events and at the same time have demonstrated a reduction in the cumulative risk of progression of AMD from intermediate to advanced stages of the disease
The objective of the clinical investigation is to evaluate the performance safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 AREDS classification in one or both eyes
Clinical studies have shown that prolonged oral lutein supplementation is safe and is associated with a reduction in the risk of progression from early to advanced stages of Age-Related Macular Degeneration AMD However patient compliance due to daily oral intake of lutein tablets for a prolonged period of life is still limited Additionally an obstacle to oral supplementation is the variable absorption of lutein through the digestive route
An iontophoresis method for conveying substances into the eye has been known for some time and already used in the treatment of keratoconus In this case the substance conveyed is Riboflavin
A medical device is now available with the following intended use to combat all oxidative pathologies of the retina and macula and in particular in the prevention of AMD and in the management of the patient during the evolution of the pathology
The device consists of an iontophoresis system with scleral applicator and an ophthalmic liquid lutein solution both of which have already obtained the CE mark The system therefore includes a generator called K-IONO CE in class IIa and a kit called IONTORETINA which includes a sterile 2 ml vial of lutein CE in class IIb the forward and return electrode which consists of a scleral iontophoresis applicator and an ophthalmic liquid solution of lutein The topical application of lutein has the advantage of improving the patients compliance with lutein supplementary therapy compared to oral intake of the carotenoid Furthermore in situ application would allow high therapeutic concentrations of lutein to be reached in the macular area in a very short period of time hours compared to oral intake months Publicly available clinical data on scleral iontophoresis or lutein supplementation have not demonstrated any safety-related adverse events and at the same time have demonstrated a reduction in the cumulative risk of progression of AMD from intermediate to advanced stages of the disease
The objective of the clinical investigation is to evaluate the performance safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 AREDS classification in one or both eyes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None